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    The EU Clinical Trials Register currently displays   44157   clinical trials with a EudraCT protocol, of which   7327   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2006-005019-81
    Sponsor's Protocol Code Number:INO-0106
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2006-11-02
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedFrance - ANSM
    A.2EudraCT number2006-005019-81
    A.3Full title of the trial
    A European Open-Label, Multicentre, Phase II Study of Inolimomab in the Treatment of Primary Steroid Resistant Acute Graft versus Host Disease (aGvHD) following allogeneic Stem Cell Transplantation for Hematological Malignancies in Adult patients
    A.4.1Sponsor's protocol code numberINO-0106
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorOPi
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/01/028
    D.3 Description of the IMP
    D.3.1Product nameLEUKOTAC® (Inolimomab)
    D.3.2Product code B-B10
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNInolimomab
    D.3.9.1CAS number 152981 – 31
    D.3.9.2Current sponsor codeB-B10, BT 563
    D.3.9.3Other descriptive nameMouse monoclonal IgG1 (κ- light-chain) anti human IL-2 receptor (a- chain, p55
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    For treatment of patients with Primary Steroid Resistant Acute Graft versus Host Disease (aGvHD) following allogeneic Stem Cell Transplantation for Hematological Malignancies in Adult patients
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10018651
    E.1.2Term Graft versus host disease
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the Overall Response Rate (CR + PR) at D29 after initiation of Inolimomab in patients with Primary steroid resistant Acute Graft versus Host Disease (aGvHD) after Allogeneic Hematopoietic Stem Cell Transplantation
    E.2.2Secondary objectives of the trial
    1. To evaluate the duration of the response
    2. To determine the best response (BR) and the median time to obtain the best response
    3. To determine the effect of Inolimomab on the Transplant-Related Mortality (TRM) defined as mortality not related to the relapse of the initial disease
    4. To determine the effect of Inolimomab on the survival rate and disease free survival at D100, 6 months and one year
    after the Stem Cell Transplantationo
    after the initiation of Inolimomab,
    5. To determine the effect of Inolimomab on transplantation by assessing the incidence of chronic GvHD, infections (bacterial and fungal) and Post-Transplant Lymphoproliferative disease and relapse of haematological malignancy
    6.To determine the patients viral status evolution (CMV and EBV reactivation and other virus)
    7. Safety profile and presence of HAMAs
    8. To study immunophenotypage during Inolimomab treatment,
    9. To study PK of Inolimomab in 20 enrolled patients
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age ≥ 18 years
    2. First allogeneic bone marrow or peripheral Stem Cell Transplantation from HLA-matched sibling donor or 10/10 HLA unrelated donor for hematological malignancy
    3. Patient must have received either a myeloablative or non myeloablative regimen, but in any case with no ATG treatment.
    4. Patient must be in Complete Remission or chronic Phase (concerning the CML) or in stable disease (concerning CLL, Low grade NHL and myeloma) from the underlying Hematological malignancy at the time of the SCT
    5. GvHD prophylaxis with :·
    Short regimens (D1, D3 and D6 or D1, D3, D6 and D11) of methotrexate and cyclosporine or tacrolimus or· MMF (D1 to D28) and cyclosporine.
    6. Patient with the first episode of grade II to IV aGvHD (according to modified Glucksberg scoring system) developed within 100 days after HSCT
    7. Patients who already received MP (2mg/kg) as treatment and must have shown a resistance as defined by one of the following item:
    · GvHD progressing after 3 days;
    GvHD persisting after 7 days
    8. Patient must observe adequate birth control measures
    9.Patient must give a written informed consent (personally signed and dated) before completing any study related procedure which means assessment or evaluation that would not form part of the normal medical care of the patient
    E.4Principal exclusion criteria
    1. Post Donor Lymphocyte infusion GvHD
    2. Non HLA matched donor
    3. Transplantation other than hematological malignancy
    4. Cord Blood transfusion
    5. Patients who have received conditioning regimen with ATG
    6. Patient received Prophylactic regimens of GvHD with corticosteroids
    7. Patient on Mechanical ventilatory support
    8. Progression of the malignancy at the time of inclusion
    9. Serum creatininemia > 30 mg/l
    10. Patient with Vasopressor treatment
    11. Uncontrolled infection(s), (i.e. documented bacterial, parasitical, or fungal infection) within 72 hours prior to study entry despite adapted treatment. Neither continuation of antibiotics for a controlled infection nor prophylactic/empiric antibiotics warrant exclusion
    12. Pregnant or lactating females
    13. Use of any investigational drug for the treatment of acute GvHD within 14 days prior to study entry-
    14. Any history of hypersensitivity/allergy to murine products and any other component of study drug
    15. Positive HIV serology
    16. ECOG> 3
    17. ASAT or ALAT > 5xULN
    18. Serum Albumin ≤ 15 g/l
    19. Minor patient and those incapable of giving informed consent
    E.5 End points
    E.5.1Primary end point(s)
    Overall Response rate at D29 defined from the total number of patients achieving Complete response and Partial response (CR+PR) as defined below.
    - Complete response (CR): resolution of all clinical and biological symptoms of aGvHD,
    - Partial response (PR): reduction by one or more level of grading in overall aGvHD score without additional therapy or worsening in other organ systems
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA9
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 36
    F.4.2.2In the whole clinical trial 40
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2006-12-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-11-27
    P. End of Trial
    P.End of Trial StatusOngoing
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